Abnormal Cerebral Venous Sinus MorphologyNCT05820165
Brain Imaging in Cerebral Venous Outflow Disturbance
An observational study of Abnormal Cerebral Venous Sinus Morphology and Internal Jugular Vein Stenosis, run by Capital Medical University at 1 site in China.
Trial summary
Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormal Cerebral Venous Sinus Morphology, Internal Jugular Vein Stenosis, Image
- What is being tested?
- high-resolution 3D-T1, diffusion tensor imaging (DTI) and resting-state functional magnetic resonance imaging (rs-fMRI)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins )
Who may be able to join
- Cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins ) is confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA)
- Accompanying symptoms such as tinnitus cerebri, cognitive decline, anxiety depression, sleep disorders, etc. for more than 6 months
Who cannot join
- ear primary disease medicine related intracranial hypertension; Systemic disease of abnormal metabolism or inflammation; moderate to severe stenosis in intracranial, carotid or vertebral arteries; intracranial lesions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital;Capital Medical University
Beijin, XI Cheng District, 100053
Xunming Ji, +86-10-83198952, jixunming@vip.163.com
About this study
Official title: Study on Brain Structure and Function Imaging in Patients With Cerebral Venous Outflow Disturbance
Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. Therefore, understanding the brain structural and functional changes in patients with cerebral venous outflow disturbance is essential to provide specific imaging evaluation indicators and new diagnosis and treatment methods for patients with cerebral venous return disorders.
Read the detailed description
Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. A number of central nervous system disorders such as transient global amnesia, transient monocular blindness, primary labor headaches, and even Parkinson's have been reported to be closely associated with internal jugular vein stenosis. Other common clinical manifestations include sleep disturbances, tinnitus, tinnitus, headache, visual impairment, optic papilledema, hearing loss, cognitive decline and neck discomfort and even autonomic dysfunction. The main objective of this study is to investigate the structural and functional network changes in patients with cerebral venous outflow disturbance using different brain imaging techniques, to clarify the correlation between symptoms of cerebral venous outflow disturbance and brain structure and function; to identify areas with corresponding structural and functional changes in patients with cerebral venous outflow disturbance and or comorbid symptoms, and to provide specific imaging assessment indicators and new diagnostic and treatment tools for patients with cerebral venous outflow disturbance and comorbid symptoms.
- Being tested
- high-resolution 3D-T1, diffusion tensor imaging (DTI), resting-state functional magnetic resonance imaging (rs-fMRI), arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI), susceptibility-weighted images (SWIs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-resolution 3D-T1Radiation
Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images
diffusion tensor imaging (DTI)Radiation
Subjects undergo a DTI imaging to obtain images of white matter lesions
resting-state functional magnetic resonance imaging (rs-fMRI)Radiation
Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity
arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI)Radiation
Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions
susceptibility-weighted images (SWIs)Radiation
Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network
| Study group | Role | What they receive |
|---|---|---|
| CVOD-WS | Cerebral Venous Outflow Disturbance with symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline Receives: Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs) | |
| CVOD-WOS | Cerebral Venous Outflow Disturbance without symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline Receives: Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs) | |
| HC | Healthy control Receives: Radiation: high-resolution 3D-T1; Radiation: diffusion tensor imaging (DTI); Radiation: resting-state functional magnetic resonance imaging (rs-fMRI); Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI); Radiation: susceptibility-weighted images (SWIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
voxel-based morphometry
Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)
Measured: at admission
Secondary outcomes (1)
The amplitude of low-frequency fluctuations (ALFF)
The amplitude of low-frequency fluctuations (ALFF) is used to investigate the differences in intra-regional brain activity and inter-regional functional connectivity
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Cerebral Venous Sinus MorphologyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD.PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820165
- Sponsor's protocol ID
- COVD-BI
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luan Y, Wang C, Jiao Y, Tang T, Zhang J, Teng GJ. Prefrontal-Temporal Pathway Mediates the Cross-Modal and Cognitive Reorganization in Sensorineural Hearing Loss With or Without Tinnitus: A Multimodal MRI Study. Front Neurosci. 2019 Mar 12;13:222. doi: 10.3389/fnins.2019.00222. eCollection 2019.
PubMed 30930739
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Brain Structure and Function Imaging in Patients With Cerebral Venous Outflow Disturbance
- ClinicalTrials.gov ID
- NCT05820165
- Acronym / sponsor ID
- COVD-BI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. Therefore, understanding the brain structural and functional changes in patients with cerebral venous outflow disturbance is essential to provide specific imaging evaluation indicators and new diagnosis and treatment methods for patients with cerebral venous return disorders.
Detailed description
Cerebral venous outflow disturbance can lead to cerebral hemodynamic disturbances, altered cerebrospinal fluid dynamics, cerebral venous blood stasis, increased cerebral venous pressure and decreased cerebral perfusion, cerebral white matter sparing-like changes, and widening of retinal vessel diameter. These changes are associated with numerous neurological signs and symptoms. A number of central nervous system disorders such as transient global amnesia, transient monocular blindness, primary labor headaches, and even Parkinson's have been reported to be closely associated with internal jugular vein stenosis. Other common clinical manifestations include sleep disturbances, tinnitus, tinnitus, headache, visual impairment, optic papilledema, hearing loss, cognitive decline and neck discomfort and even autonomic dysfunction. The main objective of this study is to investigate the structural and functional network changes in patients with cerebral venous outflow disturbance using different brain imaging techniques, to clarify the correlation between symptoms of cerebral venous outflow disturbance and brain structure and function; to identify areas with corresponding structural and functional changes in patients with cerebral venous outflow disturbance and or comorbid symptoms, and to provide specific imaging assessment indicators and new diagnostic and treatment tools for patients with cerebral venous outflow disturbance and comorbid symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVOD-WS | – | Radiation: high-resolution 3D-T1, Radiation: diffusion tensor imaging (DTI), Radiation: resting-state functional magnetic resonance imaging (rs-fMRI), Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI), Radiation: susceptibility-weighted images (SWIs)Cerebral Venous Outflow Disturbance with symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline |
| CVOD-WOS | – | Radiation: high-resolution 3D-T1, Radiation: diffusion tensor imaging (DTI), Radiation: resting-state functional magnetic resonance imaging (rs-fMRI), Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI), Radiation: susceptibility-weighted images (SWIs)Cerebral Venous Outflow Disturbance without symptoms such as tinnitus cerebri，somnipathy ，anxiety ，depression and cognitive decline |
| HC | – | Radiation: high-resolution 3D-T1, Radiation: diffusion tensor imaging (DTI), Radiation: resting-state functional magnetic resonance imaging (rs-fMRI), Radiation: arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI), Radiation: susceptibility-weighted images (SWIs)Healthy control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins )
Key inclusion criteria (2 listed)
- Cerebral venous outflow disturbance( moderate to severe stenosis in cerebral venous sinus or intracranial jugular veins ) is confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA)
- Accompanying symptoms such as tinnitus cerebri, cognitive decline, anxiety depression, sleep disorders, etc. for more than 6 months
Key exclusion criteria (1 listed)
- ear primary disease medicine related intracranial hypertension; Systemic disease of abnormal metabolism or inflammation; moderate to severe stenosis in intracranial, carotid or vertebral arteries; intracranial lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-resolution 3D-T1Subjects undergo a high-resolution 3D-T1 imaging to obtain structural images | Radiation | CVOD-WOS, CVOD-WS, HC |
| diffusion tensor imaging (DTI)Subjects undergo a DTI imaging to obtain images of white matter lesions | Radiation | CVOD-WOS, CVOD-WS, HC |
| resting-state functional magnetic resonance imaging (rs-fMRI)Subjects undergo rs-fMRI to investigate the differences in intra-regional brain activity and inter-regional functional connectivity | Radiation | CVOD-WOS, CVOD-WS, HC |
| arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI)Subjects undergo arterial spin labeling (ASL) perfusion magnetic resonance imaging (MRI) to clarify the difference of cerebral blood flow (CBF) perfusion in certain regions | Radiation | CVOD-WOS, CVOD-WS, HC |
| susceptibility-weighted images (SWIs)Subjects undergo susceptibility-weighted images (SWIs) to segment the vein network | Radiation | CVOD-WOS, CVOD-WS, HC |
Primary outcome
voxel-based morphometry
Time frame: at admission
Voxel-based morphometry (VBM) is used to obtain the relative gray matter volume (GMV) and WM volume (WMV)
1 secondary outcome
The amplitude of low-frequency fluctuations (ALFF)
Time frame: at admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 30930739Luan Y, Wang C, Jiao Y, Tang T, Zhang J, Teng GJ. Prefrontal-Temporal Pathway Mediates the Cross-Modal and Cognitive Reorganization in Sensorineural Hearing Loss With or Without Tinnitus: A Multimodal MRI Study. Front Neurosci. 2019 Mar 12;13:222. doi: 10.3389/fnins.2019.00222. eCollection 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD.PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Cerebral Venous Sinus Morphology and Internal Jugular Vein Stenosis, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji (010-83199430, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voxel-based morphometry (time frame: at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.